For rule 64K-1.001, F.A.C., to repeal references to obsolete alerts and reports; for rule 64K-1.004, F.A.C., to update the required reporting time period as required by recently enacted legislation; for rule 64K-1.007, F.A.C., to update the schedule ...

 

DEPARTMENT OF HEALTH

Prescription Drug Monitoring Program

RULE NOS.:RULE TITLES:

64K-1.001Patient Advisory Alerts and Reports

64K-1.004Management and Operation of Database

64K-1.007Indicators of Controlled Substance Abuse

64K-1.008Electronic Health Recordkeeping System Integration

PURPOSE AND EFFECT: For rule 64K-1.001, F.A.C., to repeal references to obsolete alerts and reports; for rule 64K-1.004, F.A.C., to update the required reporting time period as required by recently enacted legislation; for rule 64K-1.007, F.A.C., to update the schedule of controlled substances required to be reported pursuant to recently enacted legislation; and for rule 64K-1.008, F.A.C., to provide the process for approved entities to connect electronic health recordkeeping systems to the Prescription Drug Monitoring Program system as required by recently enacted legislation.

SUMMARY: Deletes references to obsolete alerts and reports; revises the time periods for reporting dispensed controlled substances; updates the controlled substance schedules subject to the reporting requirements and provides the process for electronic health recordkeeping systems to connect with the Prescription Drug Monitoring Program system as required by recently enacted legislation.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 893.055, FS.

LAW IMPLEMENTED: 893.055, FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca Poston, Program Manager, Prescription Drug Monitoring program, 4052 Bald Cypress Way, Bin #C-16, Tallahassee, Florida 32399 or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64K-1.001 Patient Advisory Alerts and Reports.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 11-24-11, Repealed                 .         

 

64K-1.004 Management and Operation of Database.

(1) All non-exempt entities that dispense controlled substances as defined in section 893.055(1)(c), F.S., Schedules II ‒ IV, are required to register and report to the program database. Orders for administration are exempt from reporting.

(2) Dispensers must register electronically at https://pmpclearinghouse.net/registrations/new.  https://flpdmp-reporting.hidinc/ using the temporary user name “newacct” and temporary password “welcome.” A permanent user name and password will be provided electronically to successful registrants. Prior to registration, a dispenser must review the “Data Submission Dispenser Guide Certification that the dispenser has reviewed the “Dispenser’s Implementation Guide,” DH8013-PDMP, effective 7/2018 7/2015, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          06459, is required before registration can be completed.

(3) All dispensers shall electronically report dispensing information to E‑FORCSE® the program’s database as soon as possible, but no later than the close of the next business day after the day the controlled substance not more than 7 days after the controlled substance is dispensed. Extensions of time to report the dispensing of a controlled substance may be granted for no more than 30 days upon request to the program by any dispenser unable to submit data by electronic means if the dispenser provides evidence of having suffered a mechanical or electronic failure or cannot report for reasons beyond the control of the dispenser or if E‑FORCSE® the database is unable to receive submissions. A dispenser that has no dispensing transactions to report for the preceding business day seven-day period must submit a zero activity report as described in the “Data Submission Dispenser Guide “Dispenser’s Implementation Guide.”

(4) Dispensing information with errors or omissions shall be corrected and resubmitted to E‑FORCSE® the database by the reporting dispenser within one seven business day days of receiving electronic or written notice from the program manager or support staff of the error or omission.

(5) The program will file a complaint with the Department and refer to law enforcement any failure to report the dispensing of Schedules II – IV controlled substances as defined in section 893.055(1)(c), F.S.

(6) Pharmacies and registered dispensing practitioners that do not dispense controlled substances in or into this state must submit a “Notification of Exemption From Reporting,” DH8016-PDMP (effective 7/2018 7/2015), incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          06461. Exemptions must be renewed on or before February 28 in odd years by making the appropriate election on the biennial pharmacy permit renewal form or on “Renewal of Notification of Exemption from Reporting Form,” DH8018-PDMP (effective 7/2018 7/2015), incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-          06463. Pharmacies and registered dispensing practitioners seeking to begin dispensing controlled substances must notify the program electronically and be removed from the exempt list prior to registering to report to the program database.

(7)(a) A patient, health care provider, prescriber, or dispenser may submit an electronic request to the program manager for the correction of erroneous information in E‑FORCSE® the database. The request shall include:

1. A statement explaining in detail the error and the basis for the requested correction.

2. The precise change requested.

3. Documentation establishing the correct information.

4. The requester’s name, address, telephone number, and license number if licensed as a health care provider in Florida.

(b) The program manager or support staff will review all requests to correct information and will request the reporting dispenser reporting the incorrect information to correct identified errors. No correction will be made if no error is found. The program will notify the entity or person requesting the correction of the results of the review.

(8) Information reported to E‑FORCSE® will be maintained in the database available for access for a period of 2 years from the date the prescription was dispensed.

(9) Information submitted to the database by dispensers directly dispensing a controlled substance shall include the telephone number of the person for whom the prescription was written.

Rulemaking Authority 893.055 FS. Law Implemented 893.055 FS. History–New 11-24-11, Amended 2-17-16, 1-12-17,              .

 

64K-1.007 Indicators of Controlled Substance Abuse.

(1) The following behavior indicates controlled substance abuse:

A patient who within a 90-day time period: (1) obtains a prescription for a controlled substance in Schedules II, III, or IV, as defined in section 893.055(1)(c) 893.03, F.S., from more than one prescriber; and (2) is dispensed a controlled substance in Schedules II, III, or IV, as defined in section 893.055(1)(c) 893.03, F.S., from five or more pharmacies.

(2) Upon identifying a patient who exhibits or for whom the behavior outlined in subsection (1), has been exhibited, the Program Manager may provide relevant information to the identified health care practitioners who have prescribed or dispensed controlled substances to the identified patient within the 90-day period.

Rulemaking Authority 893.055 FS. Law Implemented 893.055(2) FS. History–New 5-21-12, Amended             .

 

64K-1.008 Electronic Health Record System Integration

(1) Definitions.

(a) “Approved entity” means an eligible entity that has been approved by the department to connect an electronic health record system directly to E‑FORCSE®, the prescription drug monitoring data system.

(b) “Authorized user” means a health care practitioner as defined in section 893.055(f), F.S., or his or her designee.

(c) “Electronic health record” is an electronic or digital version of a patient’s medical history, maintained over time and may include all of the key administrative clinical data relevant to that person’s medical care under a particular provider, including demographics, progress notes, problems, medications, vital signs, past medical history, immunizations, laboratory data and radiology reports. The electronic health record uses computer hardware and software for the storage, retrieval, sharing and use of health care information and data.

(d) “Eligible entity” means an organization or entity that operates or provides or makes available an electronic health record system to a health care practitioner or a designee of the practitioner.

(2) An eligible entity may apply to the department to request and receive information directly from E‑FORCSE® through an electronic health record system by completing the following steps:

(a) Complete an Integration Request Form, DH8024-PDMP, effective 7/2018, incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-####.

(b) Submit the Integration Request Form to the department.

(3) The department will review the submitted form and notify each applicant by email if the request to integrate is approved or denied.

(4) Eligible entities and authorized users may retain patient prescription monitoring information in the electronic health record and must ensure that the confidential and exemption information is not inadvertently released or accessed by unauthorized persons or entities.

(5) Only individuals authorized by sections 893.055 and 893.0551, F.S., who are active registered E‑FORCSE® users are authorized to request and receive information directly from E‑FORCSE® through an electronic health record.

(6) The department may suspend or revoke integration approval if an eligible entity or authorized user does not adhere to the department’s terms and conditions, including security and privacy requirements.  The department will immediately notify the approved entity or authorized user upon suspension or revocation of approval.

Rulemaking Authority, 893.055 FS.  Law Implemented 893.055(7) FS. History–New              .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Rebecca Poston, Program Manager, Prescription Drug Monitoring Program

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: November 21, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 21, 2018